USP, Food Fraud, and FSMA

The USP plans to make available on its website a database of published articles that report “fraudulent activities related to food ingredients,” including foods used as ingredients (e.g., milk, honey, and olive oil). The database will also be included in tabular format in the upcoming 8th Edition of the Food Chemicals Codex. An article on the development of the database and its potential applications is available here.

Various definitions of food fraud have been proposed, and the term is considered essentially synonymous with economic adulteration. The USP Expert Panel on Food Ingredient Intentional Adulterants defines intentional or economically motivated adulteration as “the fraudulent addition of nonauthentic substances or removal or replacement of authentic substances without the purchaser’s knowledge for economic gain of the seller.” In substance, that definition is consistent with FDC Act § 402(b), which deems a food adulterated “(1) if any valuable constituent has been in whole or in part omitted or abstracted therefrom; or (2) if any substance has been substituted wholly or in part therefor; or (3) if damage or inferiority has been concealed in any manner; or (4) if any substance has been added thereto or mixed or packed therewith so as to increase its bulk or weight, or reduce its quality or strength, or make it appear better or of greater value than it is.”

As we have noted, FDC Act § 402(b) has seen little use in recent years. The Food Safety Modernization Act ("FSMA") seems likely to change that. One of FSMA’s principal amendments to the FDC Act requires food facilities to implement hazard analysis and risk-based preventive controls (“HARBPC”) to ensure that, among other things, a food is not adulterated under FDC Act § 402. To that end, a facility must identify and evaluate “hazards that occur naturally, or may be unintentionally introduced” (emphasis added). However, a facility must also identify and evaluate hazards that may be intentionally introduced. The facility must then implement preventive controls to provide assurances that any such hazards “will be significantly minimized or prevented and addressed,” and that the food will not be adulterated under § 402. Because § 402 includes the provision in § 402(b) quoted above, there exists a statutory link between HARBPC and economic adulteration. With that link in mind, query whether the availability of USP’s database on food fraud effectively puts food facilities on notice that the hazards identified in that database are ones that “may be intentionally introduced.” In other words, query whether food facilities will be obligated to monitor USP’s database as part of HARBPC compliance.

Late last year the Government Accountability Office issued a report recommending that FDA do more to combat economic adulteration, and the agency has established a Working Group on Economically Motivated Adulteration (see here). That action follows a public meeting that FDA held in 2009 to gather additional information on the economic adulteration (see here). With FDA’s implementation of the HARBPC requirement just around the corner, this is an issue that deserves close monitoring.